【国外标准】 Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface

5.1 The modular interfaces of total joint prostheses are subjected to micromotion that could result in fretting and corrosion. The release of corrosion products and particulate debris could stimulate adverse biological reactions, as well as lead to accelerated wear at the articulation interface. Methods to assess the stability and corrosion resistance of the modular interfaces, therefore, are an essential component of device testing.5.2 Long-term in-vitro testing is essential to produce damage and debris from fretting of a modular interface (4, 5). The use of proteinaceous solutions is recommended to best simulate the in-vivo environment.5.3 Short-term tests often can be useful in evaluations of differences in design during device development (1-4). The electrochemical methods provide semiquantitative measures of fretting corrosion rates. The relative contributions of mechanical and electrochemical processes to the total corrosion and particulate release phenomena, however, have not been established; therefore, these tests should not be utilized to compare the effects of changes in material combinations, but rather be utilized to evaluate design changes of bore (head) and cone (stem) components.5.4 These tests are recommended for evaluating the fretting wear and corrosion of modular interfaces of hip femoral head and stem components. Similar methods may be applied to other modular interfaces where fretting corrosion is of concern.5.5 These methods are recommended for comparative evaluation of the fretting wear and corrosion of new materials, coatings, or designs, or a combination thereof, under consideration for hip femoral head and neck modular interfaces. Components for testing may be those of a manufactured modular hip device (finished product) or sample coupons, which are designed and manufactured for simulation of the head, taper, and neck region of a modular hip device.1.1 This practice describes the testing, analytical, and characterization methods for evaluating the mechanical stability of the bore and cone interface of the head and stem junction of modular hip implants subjected to cyclic loading by measurements of fretting corrosion (1-5).2 Two test methods described are as follows:1.1.1 Method I—The primary purpose of this method is to provide a uniform set of guidelines for long-term testing to determine the amount of damage by measurement of the production of corrosion products and particulate debris from fretting and fretting corrosion. Damage is also assessed by characterization of the damage to the bore and cone surfaces (4, 5).1.1.2 Method II—This method provides for short-term electrochemical evaluation of the fretting corrosion of the modular interface. It is not the intent of this method to produce damage nor particulate debris but rather to provide a rapid method for qualitative assessment of design changes which do not include material changes (1-4).1.2 This practice does not provide for judgment or prediction of in-vivo implant performance, but rather provides for a uniform set of guidelines for evaluating relative differences in performance between differing implant designs, constructs, or materials with performance defined in the context of the amount of fretting and fretting corrosion. Also, this practice should permit direct comparison of fretting corrosion data between independent research groups, and thus provide for building of a data base on modular implant performance.1.3 This practice provides for comparative testing of manufactured hip femoral heads and stems and for coupon-type specimen testing where the male taper portion of the modular junction does not include the entire hip implant, with the taper portion of the coupon identical in design, manufacturing, and materials to the taper of the final hip implant (4, 5).1.4 Method I of this practice permits simultaneous evaluation of the fatigue strength of a femoral hip stem (in accordance with Practice F1440) and the mechanical stability and debris generated by fretting and fretting corrosion of the modular interface.1.5 The general concepts and methodologies described in this practice could be applied to the study of other modular interfaces in total joint prostheses.1.6 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.1.7 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.1.8 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.